Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices

Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices

Currently, disinfectants and sterilants that are intended for use on medical devices are regulated as drugs under the Food and Drug Regulations. However, Health Canada has communicated that they intend to reclassify these products as medical devices which means that disinfectants and sterilants used on medical devices would be subject to the requirements of the Medical Device Regulations.

The intent of this reclassification is to better align the classification and regulatory requirements of these products with other jurisdictions in which these products are classified as medical devices.